Maxima XTEND Handpiece Maintenance System— 510(k) K143183

Substantially Equivalent

Handpiece Headquarters

FDA 510(k) clearance K143183 for Maxima XTEND Handpiece Maintenance System, Substantially Equivalent on 2015-02-17. Applicant: Handpiece Headquarters.

Clearance details

Applicant: Handpiece Headquarters
Product code: Code EFB
Advisory panel: Dental
Date received: 2014-11-05
Decision date: 2015-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.